throbber
US 20040226566A1
`
`(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2004/0226566 A1
`Gunaratnam et al.
`(43) Pub. Date:
`Nov. 18, 2004
`
`(54) NASAL ASSEVIBLY
`
`(75)
`
`Inventors: Michael K. Gunaratnam, Marsfield
`(AL); Philip R. Kwok, Chatswood
`(AL); Robin G. Hitchcock, North
`Parramatta (AU); Lee J. Veliss, West
`Ryde (AU); Memduh Guney, Killara
`(AL); Richard Sokolov, Earlwood
`(AL); Perry D. Lithgow, Glenwood
`(AL); Donald Darkin, Dural (AU);
`Susan R. Lynch, Epping (AU)
`
`Correspondence Address:
`NIXON & VAVDERHYE, PC
`1100 N GLEBE ROAD
`8TH FLOOR
`ARLINGTON, VA 22201-4714 (US)
`
`Assignee; ResMed Limited, North Ryde (AU)
`
`Appl. No.:
`
`10/781,929
`
`Filed:
`
`Feb. 20, 2004
`
`Related U.S. Application Data
`
`Provisional application No. 60/529,696, filed on Dec.
`16, 2003. Provisional application No. 60/494,119,
`
`filed on Aug. 12, 2003. Provisional application No.
`60/448,465, filed on Feb. 21, 2003. Provisional appli-
`cation No. 60/482,872, filed on Jun. 27, 2003. Pro-
`visional application No. 60/488,810, filed on Jul. 22,
`2003.
`
`Publication Classification
`
`..
`
`.
`
`(51)
`(52)
`
`(57)
`
`ABSTRACT
`
`A62B 18/02
`...... ..128/207.18
`
`A nasal assembly for delivering breathable gas to a patient
`includes a frame having an integrally formed first connector
`portion. A nozzle assembly includes a gusset or base portion
`and a pair of nozzles. At least one inlet conduit is structured
`to deliver breathable gas into the frame and nozzle assembly
`for breathing by the patient. A pair of second connector
`portions are removably and rotatably connected to respec-
`tive first connector portions of the frame and are in com-
`munication with respective inlet conduits, e.g., directly or
`via angle connectors. A headgear assembly is removably
`connected to the pair of second connector portions and/or
`the angle connectors so as to maintain the frame and the
`nozzle assembly in a desired adjusted position on the
`patient’s face.
`
`1
`
`RMD 1004
`
`

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`Patent Application Publication Nov. 18, 2004 Sheet 1 of 109
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`2
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`Patent Application Publication Nov. 18, 2004 Sheet 2 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 3 of 109
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`50
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`58
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`58
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`50
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`4
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`Patent Application Publication Nov. 18, 2004 Sheet 4 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 6 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 8 of 109
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`US 2004/0226566 A1
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`vsv
`M
`
`SPACING
`
`FIG. 20
`
`SPAGNG
`
`FIG. 19
`
`9
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 9 of 109
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`US 2004/0226566 A1
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`AVERAGE
`
`00
`
`0.4
`
`0.5
`
`0.6
`
`0.7
`
`0.8
`
`FIG. 22
`
`Q
`
`DISTANCE FROM
`CENTRE OF NOSTRIL
`TO UPPER LIP
`
`10
`
`

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`Patent Application Publication Nov. 18, 2004 Sheet 10 of 109
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`US 2004/0226566 A1
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`FIG. 25
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`11
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`Patent Application Publication Nov. 18, 2004 Sheet 11 of 109
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`12
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`Patent Application Publication Nov. 18, 2004 Sheet 12 of 109
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`13
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`Patent Application Publication Nov. 18, 2004 Sheet 13 of 109
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`14
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`Patent Application Publication Nov. 18, 2004 Sheet 14 of 109
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`226
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`15
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`Patent Application Publication Nov. 18, 2004 Sheet 15 of 109
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`US 2004/0226566 A1
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`ANTERIOR
`AURLCLE
`LINE
`
`POSTERIOR
`AURICLE
`LINE
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`V
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`FRANKFURT
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`HORIZONTAL
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`SUBNASAL LINE
`
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`FIG. 36
`
`16
`
`16
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 16 of 109
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`US 2004/0226566 A1
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`
`
`
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`FRANKFURT
`HORIZONTAL
`LINE
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`SUBNASAL LINE
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`FIG. 37
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`17
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`Patent Application Publication Nov. 18, 2004 Sheet 17 of 109
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`US 2004/0226566 A1
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`398
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`FIG 38B
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`18
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`18
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`Patent Application Publication Nov. 18, 2004 Sheet 18 of 109
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`398
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`19
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`Patent Application Publication Nov. 18, 2004 Sheet 19 of 109
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`US 2004/0226566 A1
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`332 324
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`FIG. 40
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`330
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`20
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`Patent Application Publication Nov. 18, 2004 Sheet 20 of 109
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`350
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`FIG. 44
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`343
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`316
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`318
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`21
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`21
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 21 of 109
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`US 2004/0226566 A1
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`Fcheek friction
`+
`Flower straps
`
`Fnose reodion
`F
`
`.
`headgear tension
`
`Flip reodion
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`‘
`Flip friction
`
`FIG. 46
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`Patent Application Publication Nov. 18, 2004 Sheet 22 of 109
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`US 2004/0226566 A1
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`Patent Application Publication Nov. 18, 2004 Sheet 23 of 109
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`US 2004/0226566 A1
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`384
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`FIG. 48B
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`Patent Application Publication Nov. 18, 2004 Sheet 25 of 109
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`US 2004/0226566 A1
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`FIG. 50
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`26
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`26
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 26 of 109
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`US 2004/0226566 A1
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`27
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 27 of 109
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`28
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 28 of 109
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`29
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`29
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 29 of 109
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`30
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 30 of 109
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`US 2004/0226566 A1
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`FIG. 57
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`31
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 31 of 109
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`US 2004/0226566 A1
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`32
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 32 of 109
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`US 2004/0226566 A1
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`33
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`Patent Application Publication Nov. 18, 2004 Sheet 33 of 109
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`US 2004/0226566 A1
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`Patent Application Publication Nov. 18, 2004 Sheet 34 of 109
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`US 2004/0226566 A1
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`35
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`35
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`‘cation Nov. 18, 2004 Sheet 35 of 109
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`US 2004/0226566 A1
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`36
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`Patent Application Publication Nov. 18, 2004 Sheet 36 of 109
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`US 2004/0226566 A1
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`37
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`Patent Application Publication Nov. 18, 2004 Sheet 37 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 38 of 109
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`US 2004/0226566 A1
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`39
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 39 of 109
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`US 2004/0226566 A1
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`40
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`

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`Patent Application Publication Nov. 18, 2004 Sheet 40 of 109
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`US 2004/0226566 A1
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`41
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`Patent Application Publication Nov. 18, 2004 Sheet 41 of 109
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`US 2004/0226566 A1
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`42
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`Patent Application Publication Nov. 18, 2004 Sheet 42 of 109
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`US 2004/0226566 A1
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`561
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`562
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`43
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`Patent Application Publication Nov. 18, 2004 Sheet 43 of 109
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`US 2004/0226566 A1
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`FIG, 74B
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`44
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`Patent Application Publication Nov. 18, 2004 Sheet 44 of 109
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`45
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`Patent Application Publication Nov. 18, 2004 Sheet 45 of 109
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`US 2004/0226566 A1
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`0
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`FIG. 76B
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`46
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`Patent Application Publication Nov. 18, 2004 Sheet 46 of 109
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`US 2004/0226566 A1
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`FIG. 76D
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`47
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`Patent Application Publication Nov. 18, 2004 Sheet 47 of 109
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`US 2004/0226566 A1
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`588
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`48
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`Patent Application Publication Nov. 18, 2004 Sheet 48 of 109
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`US 2004/0226566 A1
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`49
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`Patent Application Publication Nov. 18, 2004 Sheet 49 of 109
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`50
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`Patent Application Publication Nov. 18, 2004 Sheet 50 of 109
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`51
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`Patent Application Publication Nov. 18, 2004 Sheet 51 of 109
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`52
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`Patent Application Publication Nov. 18, 2004 Sheet 52 of 109
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`53
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`Patent Application Publication Nov. 18, 2004 Sheet 53 of 109
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`US 2004/0226566 A1
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`54
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`Patent Application Publication Nov. 18, 2004 Sheet 54 of 109
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`44
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`Patent Application Publication Nov. 18, 2004 Sheet 55 of 109
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`US 2004/0226566 A1
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`56
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`Patent Application Publication Nov. 18, 2004 Sheet 56 of 109
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`57
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`Patent Application Publication Nov. 18, 2004 Sheet 58 of 109
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`US 2004/0226566 A1
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`Patent Application Publication Nov. 18, 2004 Sheet 60 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 61 of 109
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`62
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`Patent Application Publication Nov. 18, 2004 Sheet 62 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 63 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 64 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 65 of 109
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`US 2004/0226566 A1
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`US 2004/0226566 A1
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`Patent Application Publication Nov. 18, 2004 Sheet 69 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 70 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 71 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 78 of 109
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`Patent Application Publication Nov. 18, 2004 Sheet 79 of 109
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`US 2004/0226566 A1
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`Nov. 18, 2004
`
`NASAL ASSEMBLY
`
`CR OSS-REFERENCE TO PRIORITY
`APPLICATIONS
`
`[0001] This application claims the benefit of U.S. provi-
`sional application No. 60/529,696, filed Dec. 16, 2003, No.
`60/494,119, filed Aug. 12, 2003, No. 60/448,465, filed Feb.
`21, 2003, No. 60/482,872, filed Jun. 27, 2003, and No.
`60/488,810, filed Jul. 22, 2003, each of which is incorpo-
`rated herein in its entirety.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to a nasal assembly
`used for treatment, e.g., of Sleep Disordered Breathing
`(SDB) with Continuous Positive Airway Pressure (CPAP) or
`Non-invasive Positive Pressure Ventilation (NPPV).
`
`BACKGROUND OF THE INVENTION
`
`Some nasal assemblies used in the treatment of
`[0003]
`SDB are designed for insertion into the nasal passages of the
`patien . Air or other breathable gas is supplied by a blower
`and passed along a flexible conduit to the nasal assembly.
`
`[0004] The nasal assembly generally includes a relatively
`rigid shell, e.g., a frame, and a pair of nozzles (which may
`be in he form of nasal pillows, nasal prongs, cannula, or
`nasal aulfs) that are mounted on the rigid shell and struc-
`tured o be inserted into the nasal passages of the patient.
`The nozzles are usually held in place using a headgear
`assem Jly, the relatively rigid shell and headgear assembly
`being joined using some form of connector.
`
`[0005] One form of known nasal assembly is described in
`U.S. Pat. No. 4,782,832 (Trimble et al.). Trimble discloses
`a nasal puff assembly 20 that
`includes a nasal puff 22
`adapted to be worn adjacent the nose of a patient, together
`with a harness assembly 24 adapted to be worn over the head
`of the patient. The harness assembly 24 is designed to
`operatively hold pulf 22 adjacent and partially within the
`nasal passages of the patient.
`
`[0006] The puff 22 is in the form of a generally Y-shaped
`rigid hollow plenum chamber 28 together with a pair of
`laterally spaced apart nares elements 30. Adj ustability of the
`11ares elements 30 may be provided by rotatably mounting
`the elements 30 to the plenum chamber 28 and mounting the
`elements 30 in slots permitting selective lateral positioning
`of the elements 30 with respect to each other. Also,
`the
`harness assembly 24 may be adjusted to adjust the lit and
`seal of the nares elements 30 during use. That is, the force
`required to maintain a sufficient seal is directly associated
`with the force required to maintain a desired fit. Thus,
`adjustment of the fit or stability of the nasal assembly
`directly affects the seal, which can adversely affect patient
`comfort.
`
`[0007] Other examples of nasal pillows or cannula
`mounted to rigid shells are disclosed in U.S. Pat. Nos.
`5,724,965 and 6,431,172.
`
`[0008] A nasal mask assembly manufactured by Viasys,
`i.e., Spiritus,
`includes a plenum chamber with a pair of
`adjacent or
`laterally spaced nares elements. A harness
`assembly is engaged with the plenum chamber to adjust the
`fit and seal of the nares elements during use. Similar to
`
`Tri111ble, adjustment of the lit or stability of the nasal
`assembly directly affects the seal, which can adversely affect
`patient comfort.
`
`[0009] A nasal mask assembly manufactured by InnoMed,
`i.e., Nasal Aire, includes a plenum chamber with a pair of
`adjacent or laterally spaced nares elements. The nares ele-
`ments are structured to engage within the mucosal surfaces
`or internal passages of the patient’s nose to maintain the
`nasal mask assembly on the patient’s face and to provide a
`seal. See, e.g., U.S. Pat. No. 5,533,506.
`[0010] A nasal mask assembly manufactured by Steven-
`son Industries (see U.S. Pat. No. 6,012,455), i.e., CPAP-Pro,
`includes a dental anchor, a platform, and air supply tubes
`having nasal pads, wherein the platform supports the air
`supply tubes. The dental anchor is sized to be engaged
`between the teeth in the patient’s mouth so as to retain the
`assembly in place.
`
`[0011] PCT Application Publication No. WO 00/13751
`discloses a device that includes gas delivery elements posi-
`tioned into engagement with the patient’s nose by a mouth-
`piece fitted to the patient’s teeth.
`
`[0012] A common problem with known nasal assemblies,
`such as those discussed above,
`is patient comfort. For
`example, the arongs tend to irritate the patient’s nose due to
`the tension ap Jlied by the headgear assembly that pulls the
`rigid shell anc prongs towards the patient’s nose.
`
`[0013] Ano ier problem is achievement of a sealing fit
`with the patient’s nasal passages without sacrificing patient
`comfort.
`
`[0014] Ano ier problem is irritation of the inside of the
`patien ‘s nostrils caused by contact with the prongs, e.g., an
`edge thereof.
`
`[0015] Ano ier problem is irritation of the inside of the
`patien ’s nostrils caused by air jetting (air flow irritation)
`from the prongs.
`
`[0016] Ano ier problem is adjustment of the nasal assem-
`blies relative to the nose and/or head of the patient so as to
`accommodate various shapes and angles of patient’s noses.
`
`Still another problem is the direct association
`[0017]
`between sealing and stability forces that can affect patient
`comfort.
`
`SUMMARY OF THE INVENTION
`
`[0018] One aspect of the invention is directed towards a
`nasal assembly that provides more comfort to the patient.
`
`[0019] Another aspect of the invention is directed towards
`a nasal assembly that provides an elfective seal with the
`patient’s nasal passages. Preferably, the nasal assembly is a
`nozzle assembly including nozzles which comfortably come
`into contact with the external rim of the nares and avoid the
`sensitive internal passages (e.g., mucosal surfaces or internal
`passages) of the nasal passage.
`[0020]
`Still another aspect of the invention is directed
`towards a nasal assembly that does not rely on tension from
`the headgear assembly to provide an effective seal between
`the nozzles and the patient’s nasal passages.
`
`Still another aspect of the invention is directed
`[0021]
`towards a nasal assembly that is unobtrusive.
`
`111
`
`

`
`US 2004/0226566 A1
`
`Nov. 18, 2004
`
`[0022] Still another aspect of the i11vention is directed
`towards a nasal assembly that is easy to use.
`
`[0033] FIG. 5 is a front view of a nozzle assembly of the
`nasal assembly shown in FIG. 1;
`
`[0023] Still another aspect of the invention is directed
`towards a nasal assembly that maintains a headgear adjust-
`ment setting.
`
`[0024] Still another aspect of the invention is directed
`towards a nasal assembly that helps decouple sealing and
`stability forces. Specifically, one aspect of the invention is
`directed towards a nasal assembly that is structured such that
`the stability forces that act to maintain the nasal assembly on
`the patient’s face are separated or at least better distin-
`guished froni the sealing forces that act to maintain a seal
`between the nasal assembly and the patient’s face.
`
`[0025] Yet another aspect of the invention is directed
`towards a nasal assembly that provides a greater range of
`movement for nozzles of the nasal assembly.
`
`[0026] Another aspect of the invention provides a nasal
`assembly for delivering breathable gas to a patient. The
`nasal assembly includes a frame having a main body and a
`side frame member provided on each lateral side of the main
`body, each side frame member including an integrally
`formed first connector portion. A nozzle assembly includes
`a gusset or base portion and a pair of nozzles. The nozzle
`assembly is coupled with the main body of the frame with
`the pair of nozzles structured to sealingly engage with nasal
`passages of a patient’s nose in use. A pair of inlet conduits
`are structured to deliver breathable gas into the frame and
`nozzle assembly for breathing by the patient. A pair of
`second connector portions are reniovably and rotatably
`connected to respective first oonnector portions of the frame.
`The second connector portions are in communication with
`the inlet conduits via angle connectors. Aheadgear assembly
`is removably connected to at least one of the second cori-
`nector portions and the angle connectors so as to maintain
`the frame and the nozzle assembly in a desired adjusted
`position on the patient’s face.
`
`[0027] Other aspects, features and advantages of this
`invention will become apparent from the following detailed
`description when taken in conjunction with the accompa-
`nying drawings, which are a part of this disclosure and
`which illustrate, by way of example, principles of this
`invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0028] The accompanying drawings facilitate an under-
`standing of the various embodiments of this invention. In
`such drawings:
`
`[0029] FIG. 1 is a perspective view illustrating a partial
`nasal assembly constructed in accordance with an embodi-
`ment of the invention mounted to a patient’s head and
`engaged with nasal passages of the patient;
`
`[0030] FIG. 2 is a front view of a frame of the nasal
`assembly shown in FIG. 1 with some parts removed for
`clarity;
`
`[0031] FIG. 3 is a cross-sectional View of the frame shown
`in FIG. 2;
`
`[0032] FIG. 4 is a side View of the frame shown in FIG.
`2;
`
`[0034] FIG. 6 is a front cross-sectional View of the nozzle
`assemaly shown in FIG. 5;
`
`[0035] FIG. 7 is a side view of the nozzle assembly shown
`in FIG. 5;
`
`[0036] FIG. 8 is a side cross-sectional view of the nozzle
`assemaly shown in FIG. 5;
`
`[0037] FIG. 9 is a perspective view of an embodiment of
`an inlet conduit and headgear connector assembly of the
`nasal assembly shown in FIG. 1;
`
`[0038] FIG. 10 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG. 9;
`
`[0039] FIG. 11 is a perspective view of another embodi-
`ment of an inlet conduit and headgear connector assembly
`adapted to be used with the nasal assembly shown in FIG.
`1;
`
`[0040] FIG. 12 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG. 11;
`
`[0041] FIG. 13 is a side view illustrating an over-tl1e-head
`inlet conduit routing for the nasal assembly shown in FIG.
`1;
`
`[0042] FIG. 14 is a side view illustrating an under-the-
`chin inlet conduit routing for the nasal assembly shown in
`FIG. 1;
`
`[0043] FIG. 15 is a perspective view illustrating a con-
`nector for use in routing the inlet conduits over the head of
`the patient;
`
`[0044] FIG. 16 is a perspective view illustrating a con-
`nector for use in routing the inlet conduits under the chin of
`the patient;
`
`[0045] FIG. 17 is a perspective view illustrating a flow
`generator connector for use in connecting the nasal assembly
`shown in FIG. 1 to a pressurized supply;
`
`[0046] FIG. 18 is a side view illustrating an embodiment
`of headgear components for use with the nasal assembly
`shown in FIG. 1;
`
`[0047] FIG. 19 is a schematic view illustrating a patient’s
`nose having a substantially llat alar angle;
`
`[0048] FIG. 20 is a schematic view illustrating a patient's
`nose having a substantially steep alar angle;
`
`[0049] FIG. 21 is a schematic View illustrating an embodi-
`ment of a sealing zone of a nozzle;
`
`[0050] FIG. 22 is a graph illustrating average nostril ratios
`opening/entrance;
`
`[0051] FIG. 23 is a schematic View illustrating an embodi-
`ment for calculating a base major axis of a nozzle;
`
`[0052] FIG. 24 is a schematic View illustrating an embodi-
`ment for calculating a base minor axis of a nozzle;
`
`[0053] FIG. 25 is a partial perspective view illustrating
`another embodiment of a nasal assembly mounted to a
`patien ’s head and engaged with nasal passages of the
`patien ;
`
`112
`
`

`
`US 2004/0226566 A1
`
`Nov. 18, 2004
`
`[0054: FIG. 26 is a partial fro11t perspective View of the
`nasal assembly shown in FIG. 25;
`
`[0055: FIG. 27 is a cross-sectional View of the nasal
`assem Jly shown in FIG. 25;
`
`[0056: FIG. 28 is a front perspective View of a frame of
`the nasal assembly shown in FIG. 25;
`
`[0057: FIG. 29 is a rear perspective view of the frame
`shown in FIG. 28;
`
`[0058: FIG. 30 is a partial front perspective View of a half
`of the nozzle assembly of the nasal assembly shown in FIG.
`25;
`
`[0059: FIG. 31 is a side cross-sectional View of the nozzle
`assem Jly shown in FIG. 30;
`
`[0060: FIG. 32 is a perspective View illustrating an
`embociment of an inlet conduit a11d headgear connector
`assem aly of the nasal assembly shown in FIG. 25;
`
`[0061: FIG. 33 is a rear perspective view of the inlet
`conduit and headgear connector assembly shown in FIG.
`32;
`
`[0062: FIG. 34 is a cross-sectional view of the inlet
`conduit and headgear connector assembly shown in FIG. 32
`with the flexible arms in phantom;
`
`[0063: FIG. 35 is a perspective View of a flow generator
`connector for use in connecting tubes for use with the nasal
`assem Jly shown in FIG. 25 to a pressurized supply;
`
`[0064: FIG. 36 is a side View illustrating the routing of the
`inlet conduits of the nasal assembly shown in FIG. 25;
`
`[0065: FIG. 37 is a side view illustrating the nasal assem-
`bly shown in FIG. 25 mounted to a patient’s head;
`
`[0066: FIG. 38 is a perspective View illustrating another
`embociment of a nasal assembly mounted to a patient’s head
`and engaged with nasal passages of the patient;
`
`[0067: FIG. 38B is a perspective view illustrating an inlet
`conduit and an inlet conduit and headgear connector of the
`nasal assembly shown in FIG. 38;
`
`[0068: FIG. 39 is a perspective view of the nasal assembly
`shown in FIG. 38;
`
`[0069: FIG. 40 is a perspective View of a frame of the
`nasal assembly shown in FIG. 38;
`
`[0070: FIG. 41 is a perspective view of a nozzle assembly
`of the nasal assembly shown in FIG. 38;
`
`[0071: FIG. 42 is a perspective view illustrating the
`nozzle assembly shown in FIG. 41 mounted to the frame to
`shown in FIG. 40;
`
`[0072: FIG. 43 is a cross-sectional View of the nasal
`assem Jly shown in FIG. 38;
`
`[0073: FIG. 44 is a side cross-sectional view of the nasal
`assem wly shown in FIG. 38;
`
`[0076: FIG. 47 is a cross-sectio11al view of an embodi-
`ment of an inlet conduit engaged with an embodiment of an
`angle connector for delivering breathable gas;
`
`[0077: FIG. 47B is a perspective view illustrating another
`embodiment of an inlet conduit;
`
`[0078: FIG. 48 is a cross-sectional view illustrating
`another embodiment of an inlet conduit engaged with
`another embodiment of a flow generator connector for
`delivering breathable gas;
`
`[0079: FIG. 48B is perspective View illustrating another
`embodiment of an inlet conduit;
`
`[0080: FIG. 49 is a perspective view illustrating an
`embodiment of an inlet conduit of the nasal assembly shown
`in FIG. 38;
`
`[0081: FIG. 50 is a side view illustrating the nasal assem-
`bly shown in FIG. 38 prior to engagement with nasal
`passages of the patient;
`
`[0082: FIG. 51 is a front view illustrating the nasal
`assemaly shown in FIG. 38 (in cross-section) engaged with
`nasal passages of the patient;
`
`[0083: FIG. 52 is a perspective View illustrating another
`embodiment of a nasal assembly mounted to a patient’s head
`and engaged with nasal passages of the patient with two inlet
`configurations shown;
`
`[0084: FIG. 53 is a perspective view illustrating the nasal
`assemaly shown in FIG. 52;
`
`[0085: FIG. 54 is a cross-sectional view illustrating a
`nozzle assembly being engaged with a frame of the nasal
`assemaly shown in FIG. 52;
`
`[0086: FIG. 55 is a perspective View illustrating an inlet
`conduit and headgear connector assembly of the nasal
`assemaly shown in FIG. 52;
`
`[0087: FIG. 56 is a cross-sectional view illustrating the
`inlet conduit and headgear connector assembly of the nasal
`assemaly shown in FIG. 52;
`
`[0088: FIG. 57 is a cross-sectional side view illustrating
`the nasal assembly shown in FIG. 52 about to be engaged
`with nasal passages of the patient;
`
`[0089: FIG. 58 is a front view illustrating the nasal
`assemaly shown in FIG. 52 (in cross-section) being engaged
`with nasal passages of the patient;
`
`[0090: FIG. 59 is a perspective view illustrating another
`embodiment of a nasal assembly mounted to a patient’s head
`and engaged with nasal passages of the patient;
`
`[0091: FIG. 60 is a perspective View of the nasal assembly
`shown in FIG. 59 removed from a patient’s head;
`
`[0092: FIG. 61 is an exploded view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the frame,
`nozzle assembly, and clip thereof;
`
`[0074: FIG. 45 is a side view illustrating the nasal assem-
`bly shown in FIG. 38 mounted to a patient’s head showing
`two inlet configurations;
`
`[0093: FIG. 62 is a perspective view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the clip being
`engaged with the frame and nozzle assembly;
`
`[0075: FIG. 46 is a schematic force diagram illustrating
`some of the forces that are developed when the nasal
`assem Jly shown in FIG. 38 is mounted to the patient’s head;
`
`[0094: FIG. 63 is a perspective view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the engage-
`ment between the frame, nozzle assembly, and clip;
`
`113
`
`

`
`US 2004/0226566 A1
`
`Nov. 18, 2004
`
`[0095] FIG. 64 is a partial cross—sectional View of a
`portion of the nasal assembly shown in FIG. 59 illustrating
`the engagement between the frame, nozzle assembly, and
`clip;
`
`[0096] FIG. 65 is a top perspective view ofa portion ofthe
`nasal assembly shown in FIG. 59;
`
`[0097] FIG. 65A is a partial enlarged View of the cushion
`shown in FIG. 65;
`
`[0098] FIG. 65B is a schematic diagram illustrating force
`distribution according to one aspect of the present invention;
`[0099] FIG. 66 is a rear perspective View of a portion of
`an alternative embodiment of a nasal assembly illustrating
`the engagement between the frame, nozzle assembly, and
`clip;
`
`a rear perspective illustrating the
`[0100] FIG. 67 is
`engagement between another embodiment of the frame,
`nozzle assembly, and clip;
`
`[0101] FIG. 68 is a perspective view illustrating the
`nozzle assembly shown in FIG. 66 being engaged with the
`frame shown in FIG. 66;
`
`[0102] FIG. 69 is a perspective view illustrating the
`nozzle assembly shown in FIG. 67 being engaged with the
`frame shown in FIG. 67;
`
`[0103] FIG. 70 is a perspective view illustrating the clip
`shown in FIG. 66 being engaged with the frame and nozzle
`assem Jly shown in FIG. 66;
`
`[0104] FIG. 71 is a perspective view illustrating the clip
`shown in FIG. 67 being engaged with the frame and nozzle
`assem 31y shown in FIG. 67;
`
`[0105] FIG. 72 is a perspective View of a second connec-
`tor portion of the nasal assembly shown in FIG. 59;
`
`[0106] FIG. 73 is a cross—sectional view of a portion of the
`nasal assembly shown in FIG. 59 illustrating the engage-
`ment wetween the frame, second connector portion, a11d
`angle connector;
`
`[0107] FIG. 74 is a perspective view of an angle connector
`of the nasal assembly shown in FIG. 59;
`
`[0108] FIG. 74B is a perspective similar to FIG. 74 but at
`a di erent angle;
`
`[0109] FIG. 75 is a side view of the angle connector
`shown in FIG. 74;
`
`[0110] FIG. 76 is a cross—sectional view of the angle
`connector shown in FIG. 74;
`
`[0111] FIG. 76A illustrates another embodiment of the
`present invention;
`
`[0112] FIG. 76B is an exploded view of FIG. 76A;
`[0113] FIG. 76C illustrates a second connector portion of
`the assembly of FIG. 76A;
`
`[0114] FIG. 76D illustrates an angle connector used in the
`assembly of FIG. 76A;
`
`[0115] FIG. 77 is a perspective view of a flow generator
`connector of the nasal assembly shown in FIG. 59;
`
`[0116] FIG. 78 is a cross—sectional View of the flow
`generator connector shown in FIG. 77;
`
`[0117] FIG. 79 is a cross-sectio11al view of a11 embodi-
`ment of an inlet conduit of the nasal assembly shown in FIG.
`59;
`
`[0118] FIG. 80 is a perspective View of headgear yoke of
`the headgear assembly of the nasal assembly shown in FIG.
`59;
`
`[0119] FIG. 81 is a perspective view illustrating engage-
`ment between the headgear yoke (FIG. 80) and angle
`connector (FIG. 74);
`
`[0120]
`FIG. 81;
`
`FIG. 82 is a cross-section through line 82-82 of
`
`[0121] FIG. 83 is a perspective view of a headgear buckle
`of the nasal assembly shown in FIG. 59;
`
`[0122] FIG. 84 is a perspective View of the nasal assembly
`shown in FIG. 59 illustrating the routing of the headgear
`assem 11y;
`
`[0123] FIG. 85 is another perspective View of the nasal
`assemaly shown in FIG. 59 illustrating the routing of the
`headgear assembly;
`
`[0124] FIG. 86 is a top view illustrating a nasal assembly
`constructed in accordance with an embodiment of the inven-
`tiona
`
`[0125] FIG. 87 is a side view of the nasal assembly shown
`in FIG. 86;
`
`[0126] FIG. 88 is a bottom view of the nasal assembly
`shown in FIG. 86;
`
`[0127] FIG. 89 is an exploded view of a portion of the
`nasal assembly shown in FIG. 86;
`
`[0128] FIG. 90 is a perspective view of a portion of an
`embodiment of a nasal assembly;
`
`[012

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